The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Hemochron Jr Generation Ii, Hemochron Jr Signature.
| Device ID | K974799 |
| 510k Number | K974799 |
| Device Name: | HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
| Contact | Robert Matland |
| Correspondent | Robert Matland INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-22 |
| Decision Date | 1998-07-07 |
| Summary: | summary |